Feb 28, 2023

Interim Report and Half-Year Financial Results - H1FY23 (ASX Announcement)

Interim Report and Half-Year Financial Results - H1FY23 (ASX Announcement)

Key Financials

  • Strong cash position with $44.0M as at 31 December 2022
  • Loss of $8.3M for the half-year (H1 FY22: $8.4M)
  • Revenue of $1.6M, down $0.3M on the prior corresponding period (H1 FY22: $1.9M)
  • Receipt of a $7.1M Research and Development (R&D) tax incentive in December 2022

Operational Highlights

  • Positive preliminary AZD0466 clinical data presented by Starpharma’s partner, AstraZeneca, showed that it was well tolerated in leukemia patients, with no dose-limiting toxicities reported, in an ongoing Phase 1/2 trial
  • Expansion of DEP® Antibody Drug Conjugates (ADCs) program with MSD, alongside the progression of other partnered DEP® programs, including with AstraZeneca, Genentech and Chase Sun
  • Internal clinical-stage DEP® assets, DEP® cabazitaxel, DEP® docetaxel and DEP® irinotecan, advanced, with multiple arms approaching completion of recruitment
  • Preclinical pipeline, which includes DEP® ADCs and DEP® radiotheranostics, continued to progress
  • Ongoing commercialisation of VIRALEZE™ including product launch in Hong Kong and Macau, as well as registration in Indonesia

 

Dr Jackie Fairley, Starpharma CEO said: “We are pleased with the progress made during the half-year. Starpharma signed a second DEP® research agreement with MSD in the area of ADCs; and AstraZeneca reported positive preliminary AZD0466 clinical data from its ongoing Phase 1/2 trial in patients with leukemia. These results are significant in the context of the AZD0466 clinical trial and reinforce the potential of Starpharma’s DEP® platform to deliver benefits to patients.

“Starpharma’s internally developed DEP® oncology products – DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan – also advanced, with patient recruitment for the monotherapy arms of the DEP® docetaxel and DEP® cabazitaxel Phase 2 trials now in the final stages. In addition, Starpharma’s preclinical pipeline, which includes DEP® ADCs and DEP® radiotheranostics, continued to progress. Our internal DEP® assets continue to attract interest from potential licensing and collaboration partners.

“Starpharma also continues to expand the availability of VIRALEZE™ nasal spray, which is now registered in more than 30 countries; and was launched in Hong Kong and Macau during the half-year. VivaGel® BV is now registered in more than 45 countries, with new product launches planned in Asia and the Middle East in 2023.”

 

Summary of Activities

DEP® Drug Delivery Platform

During the period, Starpharma expanded its DEP® Antibody Drug Conjugates (ADCs) program with MSD (Merck Sharp & Dohme LLC), signing a second research agreement focussed on the design and synthesis of DEP® ADCs.

In December 2022, Starpharma’s partner, AstraZeneca, presented positive preliminary AZD0466 clinical data from the ongoing Phase 1/2 trial in patients with advanced relapsed/refractory leukemia The clinical data reported showed that AZD0466 was well tolerated, with no dose-limiting toxicities (DLTs) reported and no discontinuations due to treatment-related adverse events. These results were presented by AstraZeneca at the American Society of Hematology Annual Meeting in December 2022. Patient enrolment continues for this Phase 1/2 trial at 18 sites across Europe, the United States, Asia, and Australia, with additional sites planned.

AstraZeneca’s second Phase 1/2 clinical trial of AZD0466 in patients with non-Hodgkin lymphoma continued to enrol patients, with the expansion of trial sites across the United States, Asia, and Italy. Additional sites are planned in other parts of Europe, North America and Australia.

Starpharma’s partnered DEP® programs with AstraZeneca, MSD, Genentech, and Chase Sun continued to progress. These partnerships span a number of therapeutic areas, including oncology and anti-infectives, and include DEP® ADCs.

Starpharma’s internal clinical DEP® programs for DEP® cabazitaxel, DEP® docetaxel and DEP® irinotecan were advanced, with recruitment for the monotherapy arms of these studies in the final stages.

The DEP® cabazitaxel Phase 2 trial has enrolled 76 patients, with patient recruitment in the final stages and data analysis and biostatistics activities underway. During this period, promising additional interim clinical data were reported from the cohort of late-stage prostate cancer patients in Starpharma’s Phase 2 DEP® cabazitaxel trial[1]. This cohort comprised 25 heavily pre-treated patients with metastatic castration-resistant prostate cancer across trial sites in the UK and Australia. The interim results reported showed a number of key advantages compared to published data for conventional cabazitaxel including longer progression-free survival (PFS) and improved rates of prostate-specific antigen[2] (PSA) reductions of 50% or more from baseline, as well as a lower incidence of key side effects. These benefits were observed despite this DEP® cabazitaxel patient cohort being significantly more heavily pre-treated compared with the populations reported in the published data for standard cabazitaxel clinical trials[3]. These interim results for the prostate cancer patient cohort were presented at the European Society of Medical Oncology (ESMO) Congress in September 2022.

The DEP® docetaxel clinical program continued to progress, with 76 patients enrolled across the monotherapy and combination arms. Recruitment for the monotherapy arm is in the final stages, with the final patient in screening. Encouraging efficacy signals have been observed, including in heavily pre-treated patients with lung, pancreatic, oesophageal, cholangiocarcinoma and gastric cancers.

The DEP® irinotecan Phase 2 clinical trial continued to progress, with 89 patients enrolled across the monotherapy and combination arms. Final recruitment for the monotherapy arm is focused on platinum resistant ovarian cancer, where particularly encouraging responses have been observed. Encouraging efficacy signals with DEP® irinotecan have also been observed in heavily pre-treated patients with multiple other tumour types, including colorectal, breast, pancreatic, lung, and oesophageal cancers.

During this half-year, Starpharma also commenced patient recruitment for the combination arm utilising DEP® irinotecan plus fluorouracil (5-FU) and leucovorin. The combination of standard irinotecan with 5-FU and leucovorin is a commonly used treatment regimen in patients with colorectal cancer, known as “FOLFIRI”. Patient enrolment continues for this combination arm, as well as for the DEP® docetaxel plus gemcitabine combination arm.

Commercial discussions with potential licensing partners continue for Starpharma’s internal DEP® assets: DEP® docetaxel, DEP® cabazitaxel and DEP® irinotecan.

In addition to advancing its clinical stage programs, the Company continued to progress a number of preclinical programs, including in the areas of DEP® radiotheranostics and DEP® ADCs.

Marketed Products

During the period, VIRALEZE™ was launched in Hong Kong and Macau through a network of retail stores, online and other channels, including Mannings and A.S. Watson Group’s PARKnSHOP. The launch followed the signing of a sales and distribution agreement with Hengan. Under this agreement, Starpharma supplies VIRALEZE™, with Hengan exclusively responsible for sales, final packing, distribution, and marketing in Hong Kong and Macau.

Marketing authorisation for VIRALEZE™ was recently achieved in Indonesia and discussions continue with potential distribution partners for this and other markets. In parallel, VIRALEZE™ sales and marketing activities continued elsewhere where Starpharma has distribution arrangements in place.

VIRALEZE™ is now registered in more than 30 countries[4] across various regions. In Australia, the review by the Therapeutic Goods Administration (TGA) for the SPL7013 nasal spray as a medical device is ongoing. Starpharma continues to focus on registration and commercialisation of the product in new markets, with a focus on commercially attractive markets with rapid regulatory pathways.

During the period, Starpharma commenced patient recruitment in the UK for a post-market clinical study of VIRALEZE™ in patients recently diagnosed with COVID-19. This study is intended to support ongoing regulatory, marketing, and commercial activities in multiple markets.

In vivo studies conducted at Scripps Research showed protection against infection with the SARS-CoV-2 Omicron variant in a viral challenge model. VIRALEZE™ administered nasally reduced viral load by >99.9% in the lungs and trachea of animals challenged with SARS-CoV-2 (vs. saline control). In addition, data from these studies presented at the international Respi DART meeting in December 2022 showed that VIRALEZE™ outperformed a number of marketed comparator nasal sprays in reducing SARS-CoV-2 Omicron viral load and infectious virus in the nasal cavity, lungs and trachea of animals challenged with virus following treatment with the products. These in vivo results against Omicron are consistent with previous in vitro findings showing VIRALEZE™ has the ability to trap and block multiple SARS-CoV-2 variants, including the Omicron and Delta variants.

Starpharma’s novel, non-antibiotic vaginal gel, VivaGel® BV, for the treatment of bacterial vaginosis (BV) and prevention of recurrent BV, is registered in more than 45 countries.

Starpharma continues to support marketing and regulatory activities for its VivaGel® BV partners, Mundipharma and Aspen. Registration was achieved in Kuwait during the period and new product launches are planned in countries in the Middle East and Asia.

Fleurstat BVgel marketing activities continued in Australia and New Zealand by Aspen, including digital marketing campaigns, promotional items in women’s health and lifestyle print media, as well as shopping centre advertising.

Starpharma’s VivaGel® Condom partner Okamoto continues marketing in Japan as well as regulatory activities in a number of other Asian markets.

Starpharma continues to review its existing product distribution arrangements to seek to maximise revenue opportunities in key markets.

Other 

Dr Russell Basser was appointed as a non-executive Director from 20 February 2023. Dr Basser is a medical oncologist and former corporate executive who brings over 30 years of international medical and biopharmaceutical experience to Starpharma’s Board.

Financial Summary

At 31 December 2022, Starpharma’s cash position was $44.0M. The loss for the period was $8.3M (H1 FY22: $8.4M). Research and product development expense reflects the Company’s investment in internal DEP® drug delivery programs, including DEP® cabazitaxel, DEP® docetaxel, DEP® irinotecan, DEP® ADCs and DEP® radiotheranostics. Revenue of $1.6M for the half-year was lower by $0.3M on the prior corresponding period (H1 FY22: $1.9M), with lower VIRALEZE™ product sales in H1 FY23 compared with H1 FY22, which had included the commercial launch of VIRALEZE™ in Vietnam. In December 2022, Starpharma received a $7.1M R&D tax incentive refund.

 

 For the full announcement, please see here.

 

[1] Jones RH, et al. Efficacy and safety of dendrimer-enhanced (DEP) cabazitaxel (CTX-SPL9111) in men with metastatic castration-resistant prostate cancer (mCRPC) in a phase I/II trial. Annals of Oncology, 2022;33(Suppl 7):S1186-S1187. https://doi.org/10.1016/j.annonc.2022.07.1889

[2] Progression-free survival (PFS) is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not progress. For this study, PFS was defined as the time from start of treatment to the first of PSA or radiologic progression.

[3] Eisenberger M, et al. J Clin Oncol, 2017;35(28):3198-206 

[4] VIRALEZE™ is not approved for use or supply in Australia.

 

 

 This contains certain forward-looking statements.